U.S. patent application number 16/707502 was filed with the patent office on 2020-06-18 for surgical delivery device and method of use.
This patent application is currently assigned to Medtronic 3F Therapeutics, Inc.. The applicant listed for this patent is Medtronic 3F Therapeutics, Inc.. Invention is credited to David Elizondo, Andrzej M. Malewicz, Matthew W. Weston.
Application Number | 20200188106 16/707502 |
Document ID | / |
Family ID | 43628679 |
Filed Date | 2020-06-18 |
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United States Patent
Application |
20200188106 |
Kind Code |
A1 |
Malewicz; Andrzej M. ; et
al. |
June 18, 2020 |
SURGICAL DELIVERY DEVICE AND METHOD OF USE
Abstract
A delivery device for a stented heart valve includes a handle,
an elongate shaft extending from a distal end of the handle, and a
conical housing having a proximal end coupled to the elongate shaft
and an open distal end, the conical housing having a conical lumen
therein with a first internal diameter adjacent to the proximal end
of the conical housing and a larger second internal diameter
adjacent to the open distal end of the conical housing.
Inventors: |
Malewicz; Andrzej M.;
(Minneapolis, MN) ; Elizondo; David; (Plymouth,
MN) ; Weston; Matthew W.; (Roseville, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic 3F Therapeutics, Inc. |
Irvine |
CA |
US |
|
|
Assignee: |
Medtronic 3F Therapeutics,
Inc.
Irvine
CA
|
Family ID: |
43628679 |
Appl. No.: |
16/707502 |
Filed: |
December 9, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15381146 |
Dec 16, 2016 |
10531955 |
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16707502 |
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12870584 |
Aug 27, 2010 |
9555528 |
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15381146 |
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61238063 |
Aug 28, 2009 |
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61287030 |
Dec 16, 2009 |
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61322486 |
Apr 9, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2436 20130101;
A61F 2/2439 20130101; A61F 2/9517 20200501; A61F 2/9522 20200501;
A61F 2/2418 20130101; B25B 27/10 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; B25B 27/10 20060101 B25B027/10 |
Claims
1. A method of loading a stented heart valve into a delivery device
comprising: receiving a delivery device, the delivery device
including a handle on a proximal end, a housing on a distal end,
and a shaft extending therebetween; crimping a stented heart valve
with a crimping tool, the stented heart valve including a radially
compressible support stent, a replacement valve, and a control
suture; pushing the crimped stented heart valve into the housing of
the delivery device; pulling the control suture through the shaft
and the handle of the delivery device; and engaging the control
suture with an engagement mechanism operably coupled to the handle
of the delivery device to apply tension to the control suture such
that the crimped stented heart valve is retained within the
housing.
2. The method of claim 1, wherein the housing of the delivery
device is generally conical in shape and includes a conical lumen
therein, the conical lumen defined by a first internal diameter at
a first end of the housing adjacent to the shaft and a larger
second internal diameter at an open second end of the housing.
3. The method of claim 2, wherein the step of pulling the control
suture through the shaft further comprises inserting a stylet tool
through a lumen in the shaft in a first direction, grasping the
control suture, and pulling the stylet tool in a second direction
opposite the first direction.
4. The method of claim 3, wherein the engagement mechanism is
movable between an engaged position and a disengaged position, the
control suture being pulled through the shaft and the handle of the
delivery device when the engagement mechanism is in the disengaged
position, and the engagement mechanism applying tension to the
control suture in the engaged position.
5. The method of claim 4, wherein the engagement mechanism includes
a trigger extending outside of the housing for moving the
engagement mechanism between the engaged position and the
disengaged position.
6. The method of claim 5, wherein the engagement mechanism includes
a first elongate gripper attached to the trigger and a second
elongate gripper attached to the handle, the first elongate gripper
movable relative to the second elongate gripper between an engaged
position and a disengaged position.
7. The method of claim 6, wherein the engagement mechanism includes
at least one torsion spring operably coupled to the trigger, the
torsion spring biasing the trigger in the engaged position.
8. The method of claim 7, wherein the delivery device includes a
retention assembly operable to lock the engagement mechanism in the
disengaged position.
9. The method of claim 4 further comprising the step of cooling the
stented heart valve to make the support stent malleable prior to
crimping the stented heart valve with the crimping tool.
10. The method of claim 9, wherein the step of cooling the stented
heart valve comprises placing the stented heart valve in chilled
water.
11. The method of claim 9, wherein the step of pulling the control
suture through the shaft and the handle of the delivery device is
performed after the crimped stented heart valve has been pushed
into the housing of the delivery device.
12. The method of claim 9, wherein the control suture is partially
threaded through the shaft and the handle of the delivery device
prior to pushing the crimped stented heart valve into the housing
of the delivery device.
13. The method of claim 9, wherein the control suture is partially
threaded through the shaft and the handle of the delivery device
prior to crimping the stented heart valve with the crimping
tool.
14. The method of claim 9, wherein the stented heart valve is
pushed into the housing of the delivery device such that an inflow
end of the stented heart valve is positioned substantially adjacent
to the open second end of the housing.
15. The method of claim 14, wherein an axial length of the conical
lumen of the housing is less than an axial length of the stented
heart valve such that at least a portion of the inflow end of the
stented heart valve extends outside of the open second end of the
housing.
16. A method of delivering a stented heart valve to an implantation
site comprising: receiving a delivery device including a conical
housing, the conical housing having a conical lumen therein with a
first internal diameter adjacent to a proximal end of the conical
housing and a larger second internal diameter adjacent to a distal
end of the conical housing; loading a crimped stented heart valve
into the conical housing such that an inflow end of the stented
heart valve extends outside of the housing past the distal end;
positioning the conical housing at an implantation site; allowing
the inflow end of the stented heart valve to expand within the
implantation site; and manipulating the delivery device to expose
additional portions of the stented heart valve to allow for
expansion within the implantation site.
17. The method of claim 16, wherein the stented heart valve
includes a control suture that is engaged by an engagement
mechanism of the delivery device to retain the crimped stented
heart valve within the conical housing.
18. The method of claim 17, wherein the engagement mechanism is
movable between an engaged position and a disengaged position to
control tension placed upon the control suture.
19. The method of claim 18, wherein the engagement mechanism
includes a trigger for moving the engagement mechanism between the
engaged position and the disengaged position.
20. The method of claim 19, wherein the step of manipulating the
delivery device to expose additional portions of the stented heart
valve comprises moving the engagement mechanism from the engaged
position to the disengaged position in a controlled manner while
retracting the delivery device from the implantation site.
21. The method of claim 17 further comprising the step of manually
warming the implantation site to promote re-expansion of the
stented heart valve.
22. The method of claim 17, wherein the stented heart valve further
comprises a cloth covering on the inflow end, the control suture
being sewn into the cloth covering.
23. The method of claim 17, wherein the implantation site is an
aortic annulus.
24. The method of claim 17, wherein the step of loading a crimped
stented heart valve comprises: crimping the stented heart valve
with a crimping tool; pushing the crimped stented heart valve into
the conical housing of the delivery device; and pulling the control
suture through a shaft and a handle of the delivery device.
25. The method of claim 24 further comprising the step of cooling
the stented heart valve prior to crimping to make the stented heart
valve malleable.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 15/381,146, filed Dec. 16, 2016 which is a continuation of
U.S. patent application Ser. No. 12/870,584, filed Aug. 27, 2010,
now U.S. Pat. No. 9,555,528 which claims priority under 35 U.S.C.
.sctn. 119(e)(1) to U.S. Provisional Patent Application Serial Nos.
61/238,063, filed Aug. 28, 2009; 61/287,030, filed Dec. 16, 2009;
and 61/322,486, filed Apr. 9, 2010; the entire teachings of each of
which are incorporated herein by reference.
FIELD
[0002] The present disclosure is generally directed to a surgical
delivery device and method of use. More particularly, the present
disclosure is directed to a surgical delivery device for delivering
a stented heart valve to an implantation site.
BACKGROUND
[0003] Heart valve replacement is required when a patient's heart
valve becomes diseased or damaged. Surgically implanted heart valve
prostheses have extended the life expectancy of many patients with
defective heart valves. Such prostheses can be either mechanical or
biological (tissue valves), stented or stentless, and may be
implanted into an aortic, mitral, tricuspid, or pulmonary
position.
[0004] During a surgical procedure, the heart is typically stopped
and the patient attached to a heart/lung bypass machine that pumps
and oxygenates the patient's blood. The longer a patient is
required to rely on the artificial heart/lung bypass machine to
maintain vital functions, the greater the stress on the patient.
There is consequently a need to simplify the surgical implantation
of a heart valve prosthesis into the implantation annulus in order
to minimize both the length of surgery and the amount of time spent
on heart/lung bypass.
[0005] Stented heart valves made from flexible material or from
materials that exhibit shape memory characteristics promise less
complicated and faster valve implantation procedures. The stents
supporting the heart valves are generally cylindrical in shape and
are structured to be crimped so as to reduce their size for
delivery to a target site. The stents may be either self-expanding
or non self-expanding. Self-expanding stents may be formed from any
suitable shape memory material, such as Nitinol. Non self-expanding
stents are typically expanded via an inflation means or mechanical
expansion means. Stented heart valves are sometimes referred to as
suture-less valves because they may be implanted and secured into
the annulus without the use of sutures.
[0006] As appreciated by those of ordinary skill in the art, it is
desirable to crimp or otherwise radially compress the stent in a
substantially uniform manner to minimize the variation in pressures
applied to the stent. Such pressure variations may lead to
deformation of the stent, which may reduce the ability of the stent
to securely maintain the heart valve at the target location. Thus,
if a stent is crimped in a non-uniform manner, it is typically
either re-crimped or thrown away. Re-crimping of stents is not
desirable because the repeated application of force on the stent
may cause fatigue or weakening of the stent structure. Disposing of
poorly crimped stents is also not desirable due to the increased
costs associated with the waste. This is especially true with
stented heart valves because the stent and the heart valve are
attached together and must be disposed of as a single unit.
[0007] A number of different strategies have been used to repair or
replace a defective heart valve with a stented replacement valve.
Generally speaking, open-heart valve repair or replacement surgery
involves a gross thoracotomy, usually in the form of a median
sternotomy. In this procedure, a saw or other cutting instrument is
used to cut the sternum longitudinally and the two opposing halves
of the anterior or ventral portion of the rib cage are spread
apart. A large opening into the thoracic cavity is thus created,
through which the surgeon may directly visualize and operate upon
the heart and other thoracic contents. The patient must be placed
on cardiopulmonary bypass for the duration of the surgery.
Open-chest valve replacement surgery has the benefit of permitting
the direct implantation of the replacement valve at its intended
target site. For example, the crimped stented replacement valve may
be delivered to the target site with a delivery catheter or the
like. Once positioned in the desired location, the stent may be
re-expanded or self-expands to secure the replacement heart valve
in place by exerting radial forces against the internal walls of
the implantation annulus.
[0008] New delivery devices and methods which make the surgical
procedure more efficient and minimize the length of time of the
procedure are always needed. Furthermore, new delivery devices and
methods which provide the surgeon with improved visualization of
the stented heart valve during delivery as well as improved control
over the deployment of the stented heart valve are also needed.
SUMMARY
[0009] The present disclosure addresses the foregoing needs by
providing a novel delivery device for a stented heart valve
including a handle, an elongate shaft extending from a distal end
of the handle, and a conical housing having a proximal end coupled
to the elongate shaft and an open distal end, the conical housing
having a conical lumen therein with a first internal diameter
adjacent to the proximal end of the conical housing and a larger
second internal diameter adjacent to the open distal end of the
conical housing.
[0010] In accordance with another aspect of the present disclosure,
a novel method of loading a stented heart valve into a delivery
device includes the steps of receiving a delivery device having a
handle on a proximal end, a housing on a distal end, and a shaft
extending therebetween, crimping a stented heart valve with a
crimping tool, pushing the crimped stented heart valve into the
housing of the delivery device, pulling a control suture of the
stented heart valve through the shaft and the handle of the
delivery device, and engaging the control suture with an engagement
mechanism operably coupled to the handle of the delivery device to
apply tension to the control suture such that the crimped stented
heart valve is retained within the housing.
[0011] In accordance with another aspect of the present disclosure,
a novel method of delivering a stented heart valve to an
implantation site includes the steps of receiving a delivery device
including a conical housing, the conical housing having a conical
lumen therein with a first internal diameter adjacent to a proximal
end of the conical housing and a larger second internal diameter
adjacent to a distal end of the conical housing, loading a crimped
stented heart valve into the conical housing such that an inflow
end of the stented heart valve extends outside of the housing past
the distal end, positioning the conical housing at an implantation
site, allowing the inflow end of the stented heart valve to expand
within the implantation site, and manipulating the delivery device
to expose additional portions of the stented heart valve to allow
for expansion within the implantation site.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a perspective view of a crimping tool in
accordance with the present disclosure.
[0013] FIG. 2 is an exploded perspective view of the crimping tool
of FIG. 1.
[0014] FIGS. 3A and 3B are front and back views, respectively, of
the crimping tool of FIG. 1 illustrating a compression assembly in
an uncrimped position.
[0015] FIGS. 4A and 4B are front and back views, respectively, of
the crimping tool of FIG. 1 illustrating the compression assembly
in a crimped position.
[0016] FIG. 5 is a front view of the crimping tool of FIG. 1
illustrating a delivery device holder having a seat member aligned
with an access aperture of the crimping tool.
[0017] FIGS. 6A-6D are perspective, side, top, and bottom views,
respectively, of a compression assembly bar in accordance with the
present disclosure.
[0018] FIG. 7 is a perspective view of the compression assembly and
attached drive wheel removed from the crimping tool.
[0019] FIG. 8 is another embodiment of a compression assembly bar
in accordance with the present disclosure.
[0020] FIG. 9 is another embodiment of a compression assembly bar
in accordance with the present disclosure.
[0021] FIG. 10 is another embodiment of a compression assembly bar
in accordance with the present disclosure.
[0022] FIGS. 11A and 11B are front and back views, respectively, of
the crimping tool of FIG. 1 with a front plate removed to
illustrate movement of the compression assembly.
[0023] FIGS. 12A and 12B are perspective and side views,
respectively, of a stented heart valve that may be crimped and
delivered to a patient in accordance with the present
disclosure.
[0024] FIGS. 13A and 13B are perspective and side views,
respectively, of a delivery device in accordance with the present
disclosure.
[0025] FIGS. 14A and 14B are diagrams illustrating the operation of
a delivery device engagement mechanism in accordance with the
present disclosure.
[0026] FIG. 15 is a perspective view of an engagement mechanism
retention assembly in accordance with the present disclosure.
[0027] FIGS. 16A and 16B are diagrams illustrating the operation of
the engagement mechanism retention assembly.
[0028] FIG. 17 is a side view of a stylet tool that may be used
with the delivery device of the present disclosure.
[0029] FIG. 18 is a perspective view of the crimping tool with the
stented heart valve loaded therein.
[0030] FIG. 19 is a perspective view of the crimping tool after the
stented heart valve has been crimped.
[0031] FIG. 20 is a perspective view of the delivery device aligned
with the crimping tool.
[0032] FIG. 21 is a perspective view of the delivery device
positioned within the delivery device holder of the crimping
tool.
[0033] FIG. 22 is a perspective view of the compression assembly
illustrating a plurality of recesses forming a stepped region for
engagement with the delivery device.
[0034] FIG. 23 is a perspective view of the crimping tool
illustrating the crimped stented heart valve being loaded into the
delivery device.
[0035] FIG. 24 is a diagram illustrating a control suture of the
stented heart valve engaged by the engagement mechanism.
[0036] FIG. 25 is a perspective view of the delivery device with
the stented heart valve hanging from a distal end thereof.
[0037] FIG. 26 is a perspective view of the delivery device with
the crimped stented heart valve loaded therein and ready for
delivery to a patient.
[0038] FIGS. 27A-27C are diagrams illustrating a method of
delivering a stented heart valve to an aortic annulus in accordance
with the present disclosure.
DETAILED DESCRIPTION
[0039] The present disclosure is generally directed to devices and
methods for reducing the size of a stented heart valve and
delivering the stented heart valve to an implantation site for
deployment within a patient. In some embodiments described in
detail herein, a stented heart valve may be crimped using a
crimping tool, loaded into a delivery device, and deployed within a
patient implantation site in a controlled manner.
[0040] As will be appreciated by those of ordinary skill in the
art, the stented heart valve may be crimped or radially compressed
in any suitable manner prior to loading the heart valve into the
delivery device. Thus, the specific crimping tool embodiments set
forth herein are provided merely for purposes of example and not
limitation.
[0041] FIG. 1 is a perspective view of one embodiment of a crimping
tool 10 that may be utilized with the present disclosure. As
illustrated in FIG. 1, the crimping tool 10 generally includes a
compression assembly 12 disposed within a housing 14, an actuation
lever 16, a lever lock 18, and a delivery device holder 20. The
housing 14 includes an elongated base portion 21 that is sized and
structured to provide sufficient support and stability to the
crimping tool 10 during use. As will be appreciated by those of
ordinary skill in the art, the base portion 21 of the housing 14
may be positioned on or attached to a table or other support
surface during use of the crimping tool 10. In alternative
embodiments, the base portion 21 may be a separate structure that
is coupled to the housing 14 instead of being formed integral
therewith.
[0042] As illustrated in FIG. 1, the housing 14 of the crimping
tool 10 includes a front wall or plate 22 and a back wall or plate
23 coupled together in a spaced apart relationship so as to define
an opening 25 therebetween. The compression assembly 12 is disposed
between the front plate 22 and the back plate 23 and is operably
coupled to the actuation lever 16 such that the actuation lever 16
extends through the opening 25. As will be discussed in further
detail to follow, movement of the actuation lever in the directions
indicated by arrows 24A and 24B controls movement of the
compression assembly 12 between an uncrimped position and a crimped
position, respectively. The actuation lever 16 of FIG. 1 is
designed for manual operation by an operator, such as by grasping
and moving the actuator 16 by hand. However, alternative
embodiments of the crimping tool 10 may include actuation levers
that are operated via alternative mechanical, electrical,
hydraulic, electromechanical, or computer-controlled actuation
means without departing from the intended scope of the present
disclosure.
[0043] The housing 14 of the crimping tool 10 is described as being
formed by two spaced apart plates that are coupled together so as
to form an opening therebetween merely for purposes of example and
not limitation. Thus, numerous other housing configurations may be
used as will be appreciated by those of ordinary skill in the art.
In one alternative embodiment, the housing 14 may instead be formed
as a rear housing portion having a cavity that is structured to
receive the compression assembly 12 and a cover plate that may be
coupled to the rear housing portion such that the compression
assembly 12 is substantially enclosed therein. Furthermore, the
housing 14 may be constructed using any suitable materials
including, but not limited to, various metals or plastics.
[0044] Although not a necessary component of the present
disclosure, the lever lock 18 is hingedly coupled to the housing 14
and operable to lock the actuation lever 16 when the compression
assembly 12 is in the crimped position. As illustrated in FIG. 1,
the lever lock 18 "blocks" movement of the actuation lever 16 in
the direction indicated by arrow 24A thereby preventing
unintentional expansion of the compression assembly 12 and the
stent (not shown) positioned therein from the crimped position back
toward the uncrimped position. As discussed above, repeated cycles
of compression and expansion of a stent may lead to fatigue or
weakening of the stent structure. Thus, the lever lock 18 may be
used to ensure that the stent is only crimped a single time prior
to delivery to a patient.
[0045] The delivery device holder 20 is structured to engage a
delivery device and align the delivery device with an access
aperture 26 in the front plate 22 of the housing 14 that is sized
to allow a stent (not shown) to be passed therethrough and into the
compression assembly 12 for crimping. This alignment allows the
crimped stent to be loaded into the delivery device for subsequent
delivery to a patient. More particularly, as illustrated in FIG. 1
the delivery device holder 20 includes a sliding plate 17 having a
seat member 19 that is structured to mate with or engage the
delivery device. As will be appreciated by those of ordinary skill
in the art, the structure and contour of the seat member 19 may
vary depending upon the type of delivery device that is being
supported. The sliding plate 17 and the seat member 19 are
illustrated in FIG. 1 as separate components that are coupled
together with a suitable fastening means such as a fastener 15.
Alternatively, the sliding plate 17 and the seat member 19 may be
formed as a single, integral unit.
[0046] The sliding plate 17 is slidably coupled to the front plate
22 of the housing 14 via at least one engagement member 27
positioned within a corresponding horizontal slot 28. The delivery
device holder 20 is structured for movement in the direction
indicated by arrow 35 from a first position as illustrated in FIG.
1 wherein the seat member 19 is not aligned with a center axis of
the access aperture 26 to a second position wherein the seat member
19 is substantially aligned with the center axis of the access
aperture 26. The range of movement of the delivery device holder 20
is determined by the length of the horizontal slot 28 in the
sliding plate 17.
[0047] The delivery device holder 20 of FIG. 1 is illustrated as
including two engagement members 27 and two corresponding
horizontal slots 28 merely for purposes of example and not
limitation. Those of ordinary skill in the art will appreciate that
any number of engagement members and corresponding slots may be
used without departing form the intended scope of the present
disclosure.
[0048] FIG. 2 is an exploded perspective view of the crimping tool
10 of FIG. 1. As illustrated in FIG. 2, the crimping tool 10
further includes a drive wheel 29 that, along with the compression
assembly 12, is structured to be positioned between the front plate
22 and the back plate 23 of the housing 14. The drive wheel 29 is a
generally cylindrical structure with an open center portion,
thereby resembling a rim or ring member. The drive wheel 29 is
rotatable with respect to the housing 14 and operably coupled to
the compression assembly 12 to drive movement of the compression
assembly 12 during the crimping process. As will be appreciated by
those of ordinary skill in the art, the front plate 22 and the back
plate 23 are spaced sufficiently apart when assembled (FIG. 1) such
that the drive wheel 29 and attached compression assembly 12 may
freely rotate therebetween. The actuation lever 16 is designed to
operably engage the drive wheel 29 to initiate and control the
movement of the drive wheel 29. As will be appreciated by those of
ordinary skill in the art, the actuation lever 16 may be coupled to
the drive wheel 29 in any suitable manner, or alternatively may be
formed integral with the drive wheel 29.
[0049] With the crimping tool 10 illustrated in FIG. 2, the front
plate 22 is attachable to the back plate 23 with a plurality of
fasteners 30 that are structured to be passed though corresponding
pluralities of apertures 31 in the front plate 22, elongate spacer
elements 32 positioned between the front plate 22 and the back
plate 23, and apertures 33 in the back plate 23. The fasteners 30
may have external threads that are structured to engage with
internal threads of the apertures 31 in the front plate 22 and/or
the apertures 33 in the back plate 23. As will be appreciated by
those of ordinary skill in the art, numerous other means for
attaching the front plate 22 to the back plate 23 of the housing 14
are contemplated and within the intended scope of the present
disclosure including, but not limited to, rivets, welding, an
adhesive, or the like. Thus, threaded fasteners are described and
illustrated merely for purposes of example and not limitation.
[0050] As illustrated in FIG. 2, the compression assembly 12
includes a plurality of bars 34, a plurality of drive pins 36, and
a plurality of guide pins 38. The drive pins 36 and guide pins 38
are preferably metallic and generally cylindrical in shape,
although the pins may be constructed in various other shapes and
from various other materials without departing from the intended
scope of the present disclosure. Each of the bars 34 includes a
generally cylindrical drive pin slot 40 structured to receive one
of the drive pins 36 and a generally cylindrical guide pin slot 42
structured to receive one of the guide pins 38. The drive wheel 29
includes a plurality of generally cylindrical drive wheel slots 44
that are structured to receive the drive pins 36 to operably couple
the drive wheel 29 to the plurality of bars 34 of the compression
assembly 12. The drive pin slots 40 and/or the drive wheel slots 44
may be sized such that they have a diameter that is slightly larger
than the diameter of the drive pins 36 to allow the bars 34 to
rotate or pivot with respect to the drive wheel 29 as the drive
wheel is rotated with the actuation lever 16. The guide pin slots
42 may be sized similar to the guide pins 38 such that a friction
fit is formed therebetween, or alternatively the guide pin slots 42
may be sized larger than the guide pins 38 to allow for slight
rotation of the distal end of the bars 34.
[0051] The crimping tool 10 is described and illustrated herein as
including a single plurality of drive pins 36 and a single
plurality of guide pins 38 merely for purposes of example and not
limitation. In alternative embodiments, the compression assembly 12
may include a first plurality of drive pins structured to extend
from the drive wheel slots 44 toward the front side of the bars 34
adjacent the front plate 22 and a second plurality of drive pins
structured to extend from an opposite end of the drive wheel slots
44 toward the back side of the bars 34 adjacent the back plate 23.
Similarly, the compression assembly 12 may include a first
plurality of guide pins structured to extend from the guide pin
slots 42 in the bars 34 toward the front plate 22 and a second
plurality of guide pins structured to extend from an opposite end
of the drive pin slots 42 in the bars 34 toward the back plate
23.
[0052] The drive wheel slots 44 may be substantially equally spaced
around the circumference of the drive wheel 29. Furthermore, as
illustrated in FIG. 2 the number of drive wheel slots 44 is equal
to the number of bars 34 in the compression assembly 12. Thus, each
bar 34 includes one drive pin slot 40, one guide pin slot 42, and
is associated with one drive wheel slot 44 in the drive wheel 29.
With embodiments in which the drive wheel slots 44 are equally
spaced around the circumference of the drive wheel 29, the bars 34
are also equally spaced around the circumference of the drive wheel
29 in a spoke-like fashion.
[0053] As will be described in further detail to follow, the bars
34 are arranged to form a generally circular or polygonal chamber
50 that is structured to receive a stent (not shown) or other
element to be crimped. With the stent positioned within the chamber
50, the internal dimensions of the chamber 50 may be reduced by
manipulating the actuation lever 16 as previously discussed,
thereby moving the compression assembly 12 from an uncrimped
position to a crimped position. The extent to which the dimensions
of the chamber 50 are reduced, and thus the amount of crimping, may
be controlled by the position of the actuation lever 16. In the
embodiment of the crimping tool 10 illustrated herein, the
actuation lever 16 moves in a clockwise direction during the
crimping process. However, those of ordinary skill in the art will
appreciate that the compression assembly 12 may be modified such
that the actuation lever 16 instead moves in a counter-clockwise
direction during the crimping process.
[0054] FIGS. 3A and 3B are front and back views, respectively, of
the crimping tool 10 in accordance with the present disclosure. As
illustrated in FIG. 3A, the front plate 22 of the housing 14
includes a first plurality of radially extending elongate slots 52.
Similarly, as illustrated in FIG. 3B, the back plate 23 of the
housing 14 includes a second plurality of radially extending
elongate slots 54 that are aligned with the first plurality of
elongate slots 52. When assembled, each of the guide pins 38 is
structured to pass through a corresponding guide pin slot 42 in one
of the bars 34 as previously discussed. Additionally, each of the
guide pins 38 is designed with a length that is sufficient to allow
a first end of the guide pin 38 to extend into a corresponding one
of the elongate slots 52 in the front plate 22 and a second end of
the guide pin 38 to extend into a corresponding one of the elongate
slots 54 in the back plate 23. As will be appreciated by those of
ordinary skill in the art, the elongate slots 52 and 54 are
structured and sized to allow a predetermined amount of radial
movement of the guide pins 38 and attached bars 34 during the
crimping process to alter the dimensions of the chamber 50.
[0055] In the state of FIGS. 3A and 3B, the compression assembly 12
is in an "uncrimped" position. FIGS. 4A and 4B are front and back
views, respectively, of the crimping tool 10 illustrating the
compression assembly 12 in a "crimped" position. As will be
appreciated by those of ordinary skill in the art, the uncrimped
position of FIGS. 3A and 3B and the crimped position of FIGS. 4A
and 4B represent the two endpoints of the crimping range. Depending
upon the size of the stent (not shown) and the amount of crimping
that is desired, an operator may achieve a desirable amount of
crimping without actuating the compression assembly 12 to the fully
crimped position of FIGS. 4A and 4B.
[0056] With reference again to the uncrimped position of FIG. 3A,
the chamber 50 is defined by a first internal dimension D1, which
may approximately represent the diameter of a circle. When the
chamber 50 is in the uncrimped position, each of the guide pins 38
is positioned substantially adjacent to a first end 56 of a
corresponding elongate slot 52 in the front plate 22 as illustrated
in FIG. 3A and a first end 58 of a corresponding elongate slot 54
in the back plate 23 as illustrated in FIG. 3B. In order to
commence the crimping process to decrease the internal diameter D1
of the chamber 50, the operator may move the actuation lever 16 in
the direction indicated by arrow 24B.
[0057] As illustrated in the crimped position of FIG. 4A, the
chamber 50 is defined by a reduced second internal dimension D2,
which may also approximately represent the diameter of a circle. As
will be appreciated by those of ordinary skill in the art, a center
axis of the chamber 50 corresponds with the center axis of the
access aperture 26. When the chamber 50 is in the crimped position,
each of the guide pins 38 is positioned substantially adjacent to a
second end 60 of a corresponding elongate slot 52 in the front
plate 22 as illustrated in FIG. 4A and a second end 62 of a
corresponding elongate slot 54 in the back plate 23 as illustrated
in FIG. 4B. As the chamber 50 contracts and becomes smaller, the
internal surface defining the chamber 50 moves toward the center
axis of the chamber 50 in a substantially uniform manner such that
the chamber maintains a substantially circular configuration
throughout the crimping process. This uniform compression is the
result of the interaction between the bars 34, the drive pins 36,
the guide pins 38, and the elongate slots 52 and 54 in the housing
14.
[0058] More specifically, during the crimping process, movement of
the actuation lever 16 in the clockwise direction 24B causes the
drive wheel 29 to also move in the clockwise direction. Because the
bars 34 of the compression assembly 12 are operably coupled to the
drive wheel 29 with the drive pins 36 at a proximal end, the
proximal ends of the bars 34 are caused to rotate clockwise along
with the drive wheel 29. As discussed above, in order to allow
movement of the bars 34 relative to one another to adjust the size
of the chamber 50, the drive pins 36, drive pin slots 40, and drive
wheel slots 44 are sized such that the bars 34 are rotatable or
pivotable with respect to the drive wheel 29 along an axis through
the drive pins 36. However, the distal ends of the bars 34 are
constrained from any substantial amount of rotation due to the
engagement of the guide pins 38 with the elongate slots 52 in the
front plate 22 and the elongate slots 54 in the back plate 23. As a
result, the guide pins 38 are allowed to slide inward along the
radially extending elongate guide slots 52 and 54 to reduce the
internal diameter of the chamber 50.
[0059] As will be appreciated by those of ordinary skill in the
art, any radially compressible stent having a diameter in the
expanded state that is greater than D2 but less than D1 may be
crimped with the crimping tool 10 of the present disclosure.
Furthermore, the size of the chamber 50 in the uncrimped and
crimped positions may be modified by changing, for example, the
number, size, or shape of the bars 34 of the compression assembly
12.
[0060] As illustrated in FIGS. 3A and 4A, the delivery device
holder 20 is located in the first position wherein the seat member
19 is not aligned with the center axis of the access aperture 26.
Once the stent (not shown) or other device has been crimped within
the chamber 50, the seat member 19 of the delivery device holder 20
may be substantially aligned with the center axis of the access
aperture 26 by moving the sliding plate 17 to the position
illustrated in FIG. 5. With the seat member 19 of the delivery
device holder 20 substantially aligned with the center axis of the
access aperture 26, the crimped stent may be easily loaded into the
delivery device (not shown) for subsequent deployment within a
patient.
[0061] In the embodiment of the delivery device holder 20
illustrated herein, the engagement members 27 are externally
threaded fasteners that are structured to threadably engage
apertures in the front plate 22 of the housing 14. More
particularly, the engagement members 27 are movable from a locked
position wherein a compression force is applied to the sliding
plate 17 to maintain its position relative to the front plate 22 of
the housing 14, to an unlocked position wherein the compression
force is released and the sliding plate 17 is movable relative to
the front plate 22. Prior to commencing movement of the sliding
plate 17, the engagement members 27 are first rotated in a
counter-clockwise direction 51A as illustrated in FIG. 4A. Rotating
the engagement members 27 in such a manner releases the compression
force applied to the sliding plate 17. After releasing the
compression force by moving the engagement members 27 from the
locked to the unlocked position, the delivery device holder 20 may
be slid to the position illustrated in FIG. 5 to substantially
align the seat member 19 with the center axis of the access
aperture 26. Once the seat member 19 has been properly aligned, the
engagement members 27 may be rotated in a clockwise direction 51B
as illustrated in FIG. 5 to prevent subsequent movement of the
delivery device holder 20 relative to the front plate 22 of the
housing 14.
[0062] Although movement of the delivery device holder 20 has been
described as occurring after the compression assembly 12 has been
actuated to the crimped position, those of ordinary skill in the
art will appreciate that the seat member 19 may be aligned with the
center axis of the access aperture 26 at any time without departing
from the intended scope of the present disclosure. For example, the
seat member 19 of the delivery device holder 20 may be aligned with
the center axis of the access aperture 26 prior to actuating the
actuation lever 16 to commence the crimping process.
[0063] FIGS. 6A-6D are perspective, side, top, and bottom views,
respectively, of one of the bars 34 in accordance with the present
disclosure. As illustrated in FIGS. 6A-6D, the bar 34 includes a
proximal end 53, a distal end 55, a front face 70, a back face 72,
a first side face 74, a second side face 76, and a chamfered
leading edge 78. The first and second side faces 74 and 76 are
substantially straight or planar surfaces that are generally
parallel to one another. The second side face 76 opposes and
intersects the chamfered leading edge 78 near the distal end 55. As
further illustrated in FIGS. 6A-6D, a proximal portion of the bar
34 comprises a front leg 80A and a back leg 80B separated by a
proximal opening 82 that is sized similar to or slightly larger
than a width of the drive wheel 29. In the illustrated embodiment,
the drive pin slot 40 extends through both the front leg 80A and
the back leg 80B. However, in alternative embodiments, the drive
pin slot 40 may extend completely through either the front leg 80A
or the back leg 80B and only partially through the other of the
front leg 80A or the back leg 80B as will be appreciated by those
of ordinary skill in the art.
[0064] Although the distal end 55 is illustrated as comprising a
substantially flat chamfered leading edge 78, the leading edge 78
may alternatively be structured with a non-flat, curvilinear,
and/or rounded surface without departing from the intended scope of
the present disclosure.
[0065] As illustrated in FIG. 6B, the centers of the drive pin slot
40 and the guide pin slot 42 are substantially aligned with a bar
axis A extending through a center plane of the bar 34. However, in
alternative embodiments, the drive pin slot 40 and/or the guide pin
slot 42 may be offset from the bar axis A. As will be appreciated
by those of ordinary skill in the art, offsetting the drive pin
slot 40 and/or the guide pin slot 42 may provide additional
tolerance for movement of the bars 34 through the crimping range of
the compression assembly 12.
[0066] The bars 34 may be constructed using any suitable material
as will be appreciated by those of ordinary skill in the art.
Exemplary materials may include, but are not limited to, polymeric
materials, polycarbonate materials, thermoplastic materials,
ceramic materials, composite materials, metallic materials, and the
like.
[0067] FIG. 7 is a perspective view of the compression assembly 12
and the drive wheel 29 removed from the crimping tool to illustrate
the positioning of the drive wheel 29 relative to the bars 34 of
the compression assembly 12. As illustrated in FIG. 7, the drive
wheel 29 is structured and sized to be positioned within the
proximal opening 82 between the front leg 80A and the back leg 80B
of the bars 34. As previously discussed, the compression assembly
12 is operably coupled to the drive wheel 29 by inserting the drive
pin 36 through the drive pin slot 40 in the front and back legs 80A
and 80B and the drive wheel slot 44 of the drive wheel 29
positioned therebetween.
[0068] FIG. 8 is a side view of an alternative embodiment bar 34A
in accordance with the present disclosure. As illustrated in FIG.
8, the bar 34A is substantially similar to the bar 34 previously
described in detail with reference to FIGS. 6A-6D. However, instead
of the drive pin slot 40 and the guide pin slot 42 of the bar 34A
being in substantial alignment with the bar axis A, the guide pin
slot 42 of the bar 34A is offset from the bar axis A. As will be
appreciated by those of ordinary skill in the art, the guide pin
slot 42 may be offset in either direction, i.e. toward the first
side face 74 or the second side face 76, without departing from the
intended scope of the present disclosure.
[0069] FIG. 9 is a side view of another alternative embodiment bar
34B in accordance with the present disclosure. As illustrated in
FIG. 9, the bar 34B is substantially similar to the bar 34
previously described in detail with reference to FIGS. 6A-6D.
However, instead of the drive pin slot 40 and the guide pin slot 42
of the bar 34B being in substantial alignment with the bar axis A,
the drive pin slot 40 of the bar 34B is offset from the bar axis A.
As will be appreciated by those of ordinary skill in the art, the
drive pin slot 40 may be offset in either direction, i.e. toward
the first side face 74 or the second side face 76, without
departing from the intended scope of the present disclosure.
[0070] FIG. 10 is a side view of another alternative embodiment bar
34C in accordance with the present disclosure. As illustrated in
FIG. 10, the bar 34C is a "hybrid" of the bar 34A of FIG. 8 and the
bar 34B of FIG. 9 wherein both the drive pin slot 40 and the guide
pin slot 42 are offset from the bar axis A. As will be appreciated
by those of ordinary skill in the art, the drive pin slot 40 and
the guide pin slot 42 may either be offset on opposite sides of the
bar axis A or on the same side of the bar axis A without departing
from the intended scope of the present disclosure.
[0071] FIG. 11A is a front view of the crimping tool 10 with the
front plate 22 (FIG. 2) removed illustrating the compression
assembly 12 in the uncrimped position. As illustrated in FIG. 11A,
the bars 34 are equally spaced around the drive wheel 29 and
arranged such that the chamfered leading edge 78 of one bar 34 is
slidable upon the second side face 76 of an adjacent bar 34 during
the crimping process. Further, a perimeter of the chamber 50 is
defined by an exposed portion 86 of the second side face 76 of each
of the bars 34.
[0072] FIG. 11B is a front view of the crimping tool 10 with the
front plate 22 (FIG. 2) removed illustrating the compression
assembly 12 in the crimped position. As illustrated in FIG. 11B,
the proximal ends of the bars 34 have rotated clockwise by a
predetermined amount R relative to the uncrimped position. The
distal ends of the bars 34 are constrained from any substantial
amount of rotation due to the interaction of the guide pins 38 with
the elongate slots 52 in the front plate 22 and the elongate slots
54 in the back plate 23 as previously discussed. Thus, the distal
ends of the bars 34 are guided radially inward along the elongate
guide slots 52 and 54 as the chamber 50 is contracted. As will be
appreciated by those of ordinary skill in the art, in the crimped
position illustrated in FIG. 11B there is a decrease in the size of
the chamber 50 perimeter due to a reduction in the exposed portion
86 of the second side face 76 of each of the bars 34.
[0073] The compression assembly 12 is described and illustrated
herein as including twelve bars 34. However, the number of bars 34
may be varied as will be appreciated by those of ordinary skill in
the art. For example, the requisite number of bars 34 may depend
upon a diameter of the drive wheel 29 or a width of the bars 34
between the first side face 74 and the second side face 76. Thus,
twelve bars 34 are illustrated merely for purposes of example and
not limitation.
[0074] Those of ordinary skill in the art will appreciate that the
foregoing exemplary embodiment of a crimping tool is only one type
of crimping tool that may be utilized with the delivery device and
method of the present disclosure. Any tool that is capable of
radially compressing a stented heart valve may also be used. One
acceptable construction of a delivery device that is used to
prepare a stented heart valve for deployment within a patient,
along with its method of use, will now be described. The heart
valve delivery device and method in accordance with the present
disclosure allows for the loading and delivery of a radially
compressible stented heart valve to a desired implantation position
within a patient, such as the aortic annulus. The delivery device
of the present disclosure provides the surgeon with improved
visibility when deploying the stented heart valve within the aortic
annulus and allows the stented heart valve to be radially deployed
in a controlled manner for precise anatomical placement.
[0075] FIGS. 12A and 12B are perspective and side views,
respectively, of a stented heart valve 100 that may be crimped from
a first enlarged sized to a second reduced size using the crimping
tool 10 (FIG. 1) previously described. As illustrated in FIGS. 12A
and 12B, the stented heart valve 100 is a substantially tubular
structure having a length L1 between an inflow end 102 and an
outflow end 104 and generally includes a tri-leaflet replacement
valve 106, a support stent 108, and a cloth covering 110 adjacent
the inflow end 102. As will be appreciated by those of ordinary
skill in the art, any suitable cloth material may be used such as
polyester or the like. The replacement valve 106 is attached to the
support stent 108 such that the replacement valve 106 resides
therein. The support stent 108 is a radially expandable and
collapsible structure adapted to be delivered to an implantation
site such as an aortic annulus, and may be formed from any suitable
material including, but not limited to, stainless steel or
Nitinol.
[0076] The support stent 108 has a substantially tubular
configuration and includes a plurality of longitudinally extending
support posts 114 extending between an inflow rim and an outflow
rim of the support stent 108. As illustrated in FIGS. 12A and 12B,
the support stent 108 includes three support posts 114
corresponding to the three leaflets of the replacement valve 106.
The replacement valve 106 is secured to the support stent 108 by
threading a plurality of commissural tabs 116 of the replacement
valve 106 through slots in the support posts 114.
[0077] The replacement valve 106 is illustrated and described as a
tri-leaflet valve merely for purposes of example and not
limitation. Thus, the stented heart valve 100 may include a
replacement valve having any number of valve leaflets. However, as
will be appreciated by those of ordinary skill in the art,
replacement valves having a number of leaflets other than three
will require a modified valve support structure.
[0078] As further illustrated in FIGS. 12A and 12B, the stented
heart valve 100 includes a control suture 112 that is sewn into the
cloth covering 110. The control suture 112 is threaded through a
plurality of suture apertures 118 in the cloth covering 110. In the
embodiment of the stented heart valve 100 illustrated and described
herein, one control suture 112 is threaded through a total of six
suture apertures 118, wherein two suture apertures 118 are formed
between each of the three support posts 114. However, as will be
appreciated by those of ordinary skill in the art, the number and
location of the suture apertures 118 may vary without departing
from the intended scope of the present disclosure so long as a
sufficient number of suture apertures are utilized in order to
maintain the radially compressed stented heart valve in the crimped
configuration as will be described in detail to follow. Further, a
single control suture 112 is described merely for purposes of
example and not limitation, and any number of additional disclosure
may be incorporated into the stented heart valve 100 as will be
appreciated by those of ordinary skill in the art.
[0079] FIGS. 13A and 13B are perspective and side views,
respectively, of a delivery device 130 in accordance with the
present disclosure. As illustrated in FIGS. 13A and 13B, the
delivery device 130 generally includes a handle 132, an engagement
mechanism 133 operably coupled to the handle 132, an elongate shaft
134, and a cone-shaped housing 136. The elongate shaft 134 is
coupled adjacent a proximal end 135 to the handle 132 and adjacent
a distal end 137 to the cone-shaped housing 136. The elongate shaft
134 may be coupled to the handle 132 and the cone-shaped housing
136 via any suitable coupling means including, but not limited to,
a compression fit, a threaded coupling, or an adhesive.
[0080] As illustrated in FIGS. 13A and 13B, the cone-shaped housing
136 includes a corresponding cone-shaped lumen 138 that is sized
and structured to receive the stented heart valve 100 upon
crimping. Although not required, the cone-shaped housing 136 may be
made from a suitable transparent material, such as polycarbonate or
the like, to allow the surgeon to visualize the correct anatomical
placement of the device in the aortic annulus. Further, the
cone-shaped housing 136 has a length L2 that is slightly less than
the length L1 (FIG. 12B) of the stented heart valve 100 (FIG. 12B)
to allow exposure of the inflow end 102 (FIG. 12B) in the aortic
annulus during deployment so that the surgeon can ensure correct
anatomical placement.
[0081] As further illustrated in FIG. 13B, a proximal base portion
142 of the cone-shaped housing 136 includes a central passage 144
that is structured to provide a pathway from the cone-shaped lumen
138 to a shaft lumen 146 extending longitudinally along the length
of the shaft 134 into the handle 132. When assembled, the central
passage 144 in the base portion 142 is aligned with the shaft lumen
146 to allow the control suture 112 (FIG. 12A) to be received
therein. More particularly, and as will be discussed in further
detail to follow, the control suture 112 is of a sufficient length
to extend through the shaft lumen 146 and into the handle 132 to
maintain the radially compressed stented heart valve in the crimped
configuration and allow deployment within the aortic annulus or
other implantation position.
[0082] The handle 132 of the delivery device 130 includes a handle
lumen 148 extending from a back side of the handle 132 into an
interior thereof. The handle lumen 148 is substantially aligned
with the shaft lumen 146 of the shaft 134 and the central passage
144 in the cone-shaped housing 136. The alignment of the handle
lumen 148, the shaft lumen 146, and the central passage 144
provides a substantially linear pathway for insertion of a stylet
tool through the handle 132 and into the cone-shaped housing 136 to
grasp the control suture 112 and pull the control suture 112 back
through the delivery device 130 such that the control suture 112
(FIG. 12A) extends out of the handle lumen 148.
[0083] As illustrated in FIGS. 13A and 13B, the handle 132 includes
a first handle section 147A and a second handle section 147B that
are coupled together with a suitable fastening means, such as a
plurality of threaded fasteners 149 structured to threadably engage
with a corresponding plurality of threaded apertures in the handle
132. Forming the handle 132 with two or more sections that are
coupled together allows for easier assembly of the delivery device
130. Although the first and second handle sections 147A and 147B
are described as being coupled together with a plurality of
threaded fasteners, any suitable fastening means may be used
including, but not limited to, rivets, bolts, welding, an adhesive,
or the like. Thus, threaded fasteners are described merely for
purposes of example and not limitation.
[0084] The various components of the delivery device 130, including
the handle 132, the elongate shaft 134, and the cone-shaped housing
136, may be made of any material that is suitable for use in a
surgical device, such as stainless steel or medical-grade
plastics.
[0085] FIGS. 14A and 14B are side views of the delivery device 130
with a portion of the handle 132 removed to illustrate the
operation of a first exemplary engagement mechanism 133 in
accordance with the present disclosure. Particularly, FIG. 14A
illustrates the engagement mechanism 133 in an "engaged" position
while FIG. 14B illustrates the engagement mechanism 133 in a
"disengaged" position. As illustrated in FIGS. 14A and 14B, the
engagement mechanism includes a trigger 150 that is pivotally
coupled to a pivot pin 152 extending through the trigger 150 and
connected to the first and second handle sections 147A and 147B.
The engagement mechanism 133 further includes a first elongate
gripper 154A coupled to the trigger 150 and a second elongate
gripper 154B coupled to the handle 132 such that it is stationary.
The first and second elongate grippers 154A and 154B are operable
to grip the control suture 112 (FIG. 12A) as will be hereinafter
explained.
[0086] As illustrated in FIGS. 14A and 14B, the engagement
mechanism 133 further includes a torsion spring 156 operably
coupling the trigger 150 to the housing 132. Those of ordinary
skill in the art will appreciate that the engagement mechanism 133
may include a single torsion spring 156 or alternatively multiple
torsion springs 156. In one exemplary embodiment, the engagement
mechanism 133 may include a first torsion spring positioned
adjacent a first side of the trigger 150 and the first handle
section 147A and a second torsion spring positioned adjacent a
second side of the trigger 150 and the second handle section
147B.
[0087] The torsion spring 156 of FIGS. 14A and 14B includes a first
leg 158 that is structured to engage the trigger 150 and a second
leg 160 that is structured to engage the handle 132. As will be
appreciated by those of ordinary skill in the art, the first and
second legs 158 and 160 anchor the ends of the torsion spring 156
to the trigger 150 and the housing 132, respectively. The torsion
spring 156 is structured to bias the trigger 150 in the engaged
position illustrated in FIG. 14A.
[0088] In the engaged position of FIG. 14A, the first and second
elongate grippers 154A and 154B are positioned in close proximity
or in contact with one another to substantially block the path from
the handle lumen 148 to the shaft lumen 146. In effect, the first
and second elongate grippers 154A and 154B function as a clamping
means for clamping and locking the control suture 112 (FIG. 12A)
within the handle 132 during the delivery procedure to maintain the
stented heart valve 100 (FIG. 12A) in the crimped
configuration.
[0089] In order to actuate the engagement mechanism 133 to the
disengaged position of FIG. 14B, the surgeon simply pushes down on
the trigger 150 against the force of the torsion spring 156.
Pushing the trigger 150 against the force of the torsion spring 156
will cause the spring to become "loaded" or compressed. In the
disengaged position, the first and second elongate grippers 154A
and 154B are separated from one another and the control suture 112
(FIG. 12A) is allowed to freely pass therebetween. When the control
suture 112 is properly positioned within the handle 132, the
surgeon may allow the engagement mechanism 133 to move back to the
engaged position of FIG. 14A by releasing the trigger 150.
[0090] Optionally, the engagement mechanism 133 includes a
retention assembly 170 for retaining the trigger 150 in the
disengaged position of FIG. 14B wherein the first and second
elongate grippers 154A and 154B are separated from one another and
the control suture 112 is allowed to freely pass therebetween.
Although the retention assembly 170 is not a necessary component of
the engagement mechanism 133, it increases the ease-of-use of the
delivery device 130 because the surgeon is not required to keep the
trigger 150 manually depressed with one hand while pulling the
control suture 112 (FIG. 12A) through the delivery device 130 with
the other hand.
[0091] FIG. 15 is a perspective view of the trigger 150
illustrating the exemplary retention assembly 170 in accordance
with the present disclosure. As illustrated in FIG. 15, the trigger
150 includes a distal end 171, a proximal end 172, and a side face
173. The exemplary retention assembly 170 includes a coil spring
174 and a retention pin 175 that are structured and sized to be
received within a retention pin slot 176 within the side face 173
of the trigger 150. When assembled, the coil spring 174 is
partially compressed between an inside end of the retention pin
slot 176 and an adjacent end of the retention pin 175, thus biasing
the retention pin 175 in the direction indicated by arrow 178 away
from the trigger 150.
[0092] FIGS. 16A and 16B are diagrams illustrating the operation of
the retention assembly 170. Particularly, FIG. 16A is a
cross-sectional distal end view of the trigger 150 illustrating the
trigger in the engaged position wherein the first and second
elongate grippers 154A and 154B are in contact with one another as
previously illustrated in FIG. 14A. In the engaged position, the
retention pin 175 is biased toward and slidable against an internal
surface 180 of the handle 132.
[0093] FIG. 16B is a cross-sectional distal end view of the trigger
150 illustrating the trigger in the disengaged position wherein the
first and second elongate grippers 154A and 154B are separated from
one another to allow the control suture 112 to pass therebetween.
As the trigger 150 is being actuated from the engaged position of
FIG. 16A to the disengaged position of FIG. 16B, the retention pin
175 slides against the internal surface 180 of the handle 132 and
"snaps" into a mating slot 182 in the handle 132 due to the
outwardly directed spring force from the coil spring 174 to lock
the trigger 150 in the disengaged position. As illustrated in FIG.
16B, when the retention pin 175 snaps into the mating slot 182, it
pushes a push button 184 outwardly such that the push button 184
protrudes from the handle 132. With the trigger 150 locked in the
disengaged position, the surgeon may insert a stylet tool through
the handle lumen 148 and toward the cone-shaped housing 136 to
grasp and pull the control suture 112 (FIG. 12A) back through the
handle of the delivery device 130. Once the control suture 112 has
been pulled through the handle 132 of the delivery device 130, the
surgeon may once again move the engagement mechanism 133 to the
engaged position by pressing the push button 184 in the direction
indicated by arrow 186. Pressing the push button 184 in this
direction releases the retention pin 175 from the mating slot 182
causing the trigger 150 to pivot back to the engaged position
illustrated in FIG. 14A due to the force of the torsion spring 156
biasing the trigger 150 to the engaged position as previously
discussed.
[0094] Those of ordinary skill in the art will appreciate that the
retention assembly 170 has been illustrated and described as being
positioned adjacent to the first handle section 147A merely for
purposes of example and not limitation. Thus, in alternative
embodiments the position of the retention assembly 170 may be
modified, such as by positioning the retention assembly on an
opposing side of the trigger 150 adjacent to the second handle
section 147B, without departing from the intended scope of the
present disclosure.
[0095] As will be appreciated by those of ordinary skill in the
art, numerous other engagement mechanisms and retention assemblies
are possible and within the intended scope of the present
disclosure. Thus, any suitable mechanical engagement means that is
movable between an engaged position and a disengaged position to
allow a suture to be pulled through the handle and locked therein
may be used without departing from the intended scope of the
present disclosure.
[0096] FIG. 17 is a side view of a stylet tool 200 designed to be
used in conjunction with the delivery device 130 (FIG. 13A) of the
present disclosure. As illustrated in FIG. 17, the stylet tool 200
includes a flexible hook portion 202 at a distal end, a handle
portion 204 at a proximal end, and an elongate main body 206
extending therebetween. As will be appreciated by those of ordinary
skill in the art, the hook portion 202 is designed to grasp one or
more control sutures 112 (FIG. 12A) when the stylet tool 200 is
inserted through the delivery device 130 as will hereinafter be
explained.
[0097] Now that embodiments of a crimping tool and a delivery
device in accordance with the present disclosure have been set
forth in detail, methods of using the crimping tool and delivery
device to crimp a stented heart valve and deliver the heart valve
to a patient will be described. More particularly, depending on the
preference of the surgeon in operation, the stented heart valve 100
may (FIG. 12A) be loaded into the cone-shaped housing 136 of the
delivery device 130 (FIG. 13A) in several different ways.
[0098] In a first embodiment of loading a stented heart valve into
a delivery device in accordance with the present disclosure, the
stented heart valve 100 (FIG. 12A) is initially placed in chilled
ice water so that the support stent 108 (FIG. 12B) becomes
malleable. As will be appreciated by those of ordinary skill in the
art, any suitable cooling means may be used to chill the support
stent 108 to make it malleable without departing from the intended
scope of the present disclosure. Once the support stent 108 has
been cooled and becomes malleable, the stented heart valve 100 is
positioned within the chamber 50 of the crimping tool 10 with the
compression assembly 12 in the uncrimped position as illustrated in
FIG. 18. More particularly, the stented heart valve 100 is inserted
into the chamber 50 such that the inflow end 102 is positioned
adjacent to the back plate 23 and the outflow end 104 is positioned
adjacent to the access aperture 26. As further illustrated in FIG.
18, the control suture 112 is positioned such that is extends
through the outflow end 104 of the stented heart valve 100 and
outside of the crimping tool 10.
[0099] [99] Next, as illustrated in FIG. 19, the actuation lever 16
of the crimping tool 10 is moved in the clockwise direction 24B to
radially crimp the stented heart valve 100 within the chamber 50.
Once the stented heart valve 100 has been fully crimped, the lever
lock 18 may be moved from the unlocked position of FIG. 18 to the
locked position of FIG. 19. As previously discussed, moving the
lever lock 18 to the locked position prevents the unintentional
expansion of the compression assembly 12 and the stented heart
valve 100 positioned therein from the crimped position back toward
the uncrimped position.
[0100] Once the stented heart valve 100 has been crimped within the
chamber 50, the cone-shaped housing 136 of the delivery device 130
may be aligned with the chamber 50 such that the cone-shaped lumen
138 is in communication with the interior of the chamber as
illustrated in FIG. 20. Then, the surgeon may slide the delivery
device holder 20 horizontally such that the seat member 19 is
aligned with the center axis of the access aperture 26 as
previously discussed in detail with regard to FIG. 5. With the seat
member 19 of the delivery device holder 20 aligned with the access
aperture, the delivery device 130 may then be engaged with the seat
member 19 as illustrated in FIG. 21.
[0101] To assist with the alignment of the cone-shaped housing 136
of the delivery device 130 with the chamber 50, each of the bars 34
of the compression assembly 12 may include a recess 210 in the
front face 70 as illustrated in FIG. 22. The plurality of recesses
210 together form a substantially circular stepped region that is
structured to mate with and receive a distal edge 212 of the
cone-shaped housing 136. In addition to assisting with the
alignment of the cone-shaped housing 136 and the chamber 50, the
stepped region formed by the plurality of recesses 210 also helps
to maintain secure engagement between the delivery device 130 and
the seat member 19 of the delivery device holder 20.
[0102] Next, an elongate cylindrical pusher tool 220 may be
inserted through an aperture 222 in the back plate 23 of the
crimping tool housing 14 as illustrated in FIG. 23 to manually push
the crimped stented heart valve 100 into the cone-shaped housing
136 of the delivery device 130. Because the length L2 of the
cone-shaped housing 136 is slightly less than the length L1 of the
stented heart valve 100, a small portion of the inflow end 102 of
the stented heart valve remains outside the cone-shaped housing
136. The exposed portion of the stented heart valve 100 in
combination with the cone-shape of the housing 136 allows the
surgeon to visualize correct anatomical placement of the heart
valve in the aortic annulus. As will be appreciated by those of
ordinary skill in the art, care should be taken to ensure that the
tail ends of the control suture 112 (hidden in FIG. 23), which may
be tied or otherwise attached together to form a continuous loop,
are exposed at the outflow end 104 (FIG. 12A) of the stented heart
valve 100 and positioned next to the central passage 144 (FIG. 13A)
of the cone-shaped housing 136. The flexible hook portion 202 (FIG.
17) of the stylet tool 200 is then inserted through the handle
lumen 148 (FIG. 13A) and positioned through the shaft lumen 146
(FIG. 13A) and the central passage 144 of the cone-shaped housing
136. The control suture 112 is then grasped by the flexible hook
portion 202 within the cone-shaped housing 136. With the trigger
150 (FIG. 14A) depressed such that the engagement mechanism 133
(FIG. 14A) is in the disengaged position, the stylet tool 200 is
pulled back through the shaft lumen 146 and the handle lumen 148 to
thread the control suture 112 through the delivery device 130. The
surgeon then manipulates the engagement mechanism 133 back to the
engaged position to grasp and lock the control suture 112 in
place.
[0103] As best seen in FIG. 24, the delivery device 130 locks and
tensions the control suture 112 in a taut position by engagement
between the first and second elongate grippers 154A and 154B. As
will be appreciated by those of ordinary skill in the art, the
tensioning of the control suture 112 maintains the stented heart
valve 100 (FIG. 23) in the radially crimped configuration
throughout the deployment of the stented heart valve into the
aortic annulus until the tension is released. As will further be
appreciated by those of ordinary skill in the art, although the
engagement mechanism 133 has been illustrated in the "fully"
engaged and "fully" disengaged positions, the surgeon may
manipulate the engagement mechanism 133 to a "partially" engaged
position wherein the first and second elongate grippers 154A and
154B maintain at least some tension on the control suture 112 but
also allow the control suture 112 to slide therebetween in a
controlled manner. This allows the surgeon to re-expand the stented
heart valve in a controlled manner during deployment within a
patient as will be discussed in further detail to follow.
[0104] Another method of loading a stented heart valve into a
delivery device in accordance with the present disclosure is
generally similar to the first exemplary method described above
with regard to FIGS. 18-24. However, instead of threading the
control suture 112 through the delivery device 130 after the
stented heart valve 100 has been crimped and pushed into the
cone-shaped housing 136, the control suture 112 is threaded
partially through the delivery device and locked by the engagement
mechanism 133 prior to pushing the stented heart valve into the
cone-shaped housing 136. Once the crimped stented heart valve has
been pushed into the cone-shaped housing 136, the excess length of
the control suture 112 may be pulled through the handle lumen 148
and once again grasped by the engagement mechanism 133 so that the
control suture 112 is taut. As will be appreciated by those of
ordinary skill in the art, the initial threading of the control
suture 112 through the delivery device 130 may be performed either
before of after the stented heart valve has been crimped.
[0105] Another embodiment of loading a stented heart valve into a
delivery device 130, the flexible hook portion 202 of the stylet
tool 200 is first inserted through the handle lumen 148 and
positioned through the shaft lumen 146 and the central passage 144
of the cone-shaped housing 136. The control suture 112 is then
grasped by the flexible hook portion 202 within the cone-shaped
housing 136. With the trigger 150 depressed such that the
engagement mechanism 133 is in the disengaged position, the stylet
tool 200 is pulled back through the shaft lumen 146 and the handle
lumen 148 to thread the control suture 112 through the delivery
device 130. The surgeon then manipulates the engagement mechanism
133 back to the engaged position to grasp and lock the control
suture 112 in an initial position in which the stented heart valve
100 hangs outside the cone-shaped housing 136 as best seen in FIG.
25. The stented heart valve 100 is then placed in chilled ice water
so that the support stent 108 becomes malleable. Once again, those
of ordinary skill in the art will appreciate that any suitable
cooling means may be used to chill the support stent 108 to make it
malleable without departing from the intended scope of the present
disclosure.
[0106] Once the support stent 108 has been cooled and becomes
malleable, the stented heart valve 100 is positioned within the
chamber 50 of the crimping tool 10, and the heart valve 100 is
crimped by actuating the actuation lever 16 as previously
described. The cone-shaped housing 136 of the delivery device 130
may then be aligned with the chamber 50 such that the cone-shaped
lumen 138 is in communication with the interior of the chamber, and
the surgeon may slide the delivery device holder 20 horizontally
such that the seat member 19 is aligned with the center of the
access aperture 26 in the housing 14. With the seat member 19 of
the delivery device holder 20 aligned with the access aperture 26,
the delivery device 130 may then be positioned within the seat
member 19. As will be appreciated by those of ordinary skill in the
art, the delivery device holder 20 may alternatively be aligned
with the access aperture and the delivery device 130 positioned
therein prior to crimping the stented heart valve 100.
[0107] Next, the elongate cylindrical pusher tool 220 may be
inserted through the aperture 222 in the back plate 23 of the
crimping tool housing 14 as previously described to manually push
the crimped stented heart valve 100 into the cone-shaped housing
136 of the delivery device 130. Once again, because the length L2
of the cone-shaped housing 136 is slightly less than the length L1
of the stented heart valve 100, a small portion of the inflow end
102 of the stented heart valve remains outside the cone-shaped
housing 136. With the engagement mechanism 133 in the disengaged
position, the surgeon then manually pulls the remaining length of
the control suture 112 through the shaft lumen 146 and handle lumen
148. The engagement mechanism 133 is then actuated back to the
engaged position to once again grasp and apply tension to the
control suture 112 to maintain the stented heart valve 100 in the
radially crimped configuration during delivery of the valve.
[0108] As will be appreciated by those of ordinary skill in the
art, the foregoing represent three stent crimping and loading
methods in accordance with the present disclosure. However,
numerous other methods are possible and within the intended scope
of the present disclosure. Further, the number and order of steps
described with regard to the three exemplary methods may be altered
as will be appreciated by those of ordinary skill in the art.
[0109] The stent crimping and loading methods have been described
with reference to the crimping tool 10 and the delivery device 130
merely for purposes of example and not limitation. Thus, the
methods in accordance with the present disclosure may be performed
using various other crimping tool and/or delivery device
embodiments without departing from the intended scope of the
present disclosure.
[0110] FIG. 26 is a perspective view of the delivery device 130
with the stented heart valve 100 loaded therein with the inflow end
102 partially exposed. After the stented heart valve 100 has been
crimped and loaded into the delivery device 130 as illustrated in
FIG. 26 using any suitable crimping and loading method, the
delivery device 130 may be positioned adjacent to the desired
implantation site for delivery of the crimped stented heart valve
100 within the implantation site.
[0111] In one embodiment as discussed above, the delivery device
130 of the present native valve may be used to deliver a crimped
stented heart valve to an aortic annulus. In order to access the
disclosure annulus, the patient may be put on bypass and the aorta
at least partially transected. Then, as illustrated in the partial
cross-sectional view of FIG. 27A the surgeon positions the delivery
device 130 within the disclosure annulus 230, pushing aside the
native leaflets 232, such that the exposed inflow end 102 is
substantially aligned with the inflow annulus of the native valve.
As will be appreciated by those of ordinary skill in the art, warm
bodily fluids cause the exposed portion of the stented heart valve
100, i.e. the inflow end 102, to start to expand to the
"remembered" shape as further illustrated in FIG. 27A.
Alternatively or in addition, the surgeon may apply a warm solution
to the implantation site to promote re-expansion of the stented
heart valve 100, such as a warm saline solution.
[0112] As the stented heart valve 100 starts to expand, the
delivery device 130 may be retracted as illustrated in FIG. 27B to
expose an additional length of the inflow end 102 of the stented
heart valve 100. As tension is slowly released from the control
suture 112 by releasing the engagement mechanism 133 from the
engaged position in a controlled manner, the inflow end 102 of the
stented heart valve 100 completely expands in the native annulus
230 where it friction fits and seals into place. The delivery
device 130 is then slowly removed from the native annulus 230 which
exposes and deploys the remainder of the stented heart valve 100 in
the native annulus 230 as illustrated in FIG. 27C. As will be
appreciated by those of ordinary skill in the art, once the stented
heart valve 100 is fully expanded within the native annulus 230,
the control suture 112 may be manually removed from the stented
heart valve in any suitable manner as it is no longer needed.
[0113] Those of ordinary skill in the art will appreciate that
heart valve delivery devices in accordance with the present
disclosure may be used for the delivery of many types of valves,
including both mitral and tricuspid valves. The cone-shape of the
housing in combination with an exposed inflow end portion of the
stented valve permits the surgeon to visualize placement of the
delivery device and the stented valve in the anatomically correct
position regardless of where the stented valve is implanted. Thus,
delivery of a stented heart valve within the disclosure annulus has
been described merely for purposes of example and not
limitation.
* * * * *